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FDA Approves LDL Cholesterol Drug

PCSK9 inhibitor targets high LDL levels in adults

Indications: Alirocumab (Praluent) injection is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol.

Mechanism: Praluent is a monoclonal antibody which targets an enzyme, PCSK9, which degrades LDL receptors on the liver which remove LDL cholesterol from the blood. By blocking PCSK9’s from degrading the LDL receptor, more receptors are available to remove LDL cholesterol from the blood, resulting in lower LDL cholesterol levels.

Dosing: The recommended starting dose is 75 mg administered subcutaneously once every 2 weeks. If LDL-C response is inadequate, the dosage may be increased to the maximum of 150 mg administered every 2 weeks.

Efficacy: In 5 placebo-controlled trials involving 2,476 participants who received Praluent, average reduction in LDL cholesterol ranged from 36% to 59%, compared to placebo.

Side Effects/Risks: The most common adverse reactions are nasopharyngitis, injection site reactions, and influenza.

Source: Highlights of Prescribing Information: Praluent (alirocumab). FDA website. Revised July 2015. Accessed July 29, 2015.